Status:
COMPLETED
Pediatric Autologous Bone Marrow Mononuclear Cells for Severe Traumatic Brain Injury
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
5-17 years
Phase:
PHASE2
Brief Summary
Pediatric severe traumatic brain injury (TBI) is the leading cause of death and disability in children ages 1-14 years old. There are no effective therapies to treat secondary brain injury and the pos...
Detailed Description
Study Design: Multicenter, randomized, blinded, placebo controlled, Bayesian adaptive dose escalation design. Study Intervention: Single dose administered within 48 hours from time of injury. Control...
Eligibility Criteria
Inclusion
- Between 5 and 17 years of age on the day of injury,
- Glasgow Coma Score (GCS) between 3 and 8, (best un-medicated post-resuscitation score during screening),
- Ability to obtain legally authorized representative (LAR) consent, and complete the BMMNC/Sham harvest and cell/placebo infusion within 48 hours of the initial injury,
- Ability to speak English or Spanish.
Exclusion
- Known history of: a. previous brain injury, b. intellectual deficiency or psychiatric condition, defined as inability to independently function in a regular classroom that may invalidate our ability to assess post-injury changes in cognition or behavior (ADHD and/or other learning disabilities are NOT an exclusion), c. neurologic impairment and/or deficit, d. seizure disorder requiring anti-convulsant therapy, e. recently treated infection, f. renal disease or altered renal function (post-resuscitation serum creatinine \> 1.5 mg/dL), g. hepatic disease or altered liver function (post-resuscitation, non-contusion related SGPT \> 150 μ/L and/or T. Bilirubin \>1.3 mg/dL), h. cancer, i. immunosuppression as defined by WBC \< 3, 000 cells/ml at admission, j. HIV+, k. chemical or ETOH dependency, l. history of child abuse, m. premature birth (\<37 weeks GA/2500 grams) resulting in cognitive/physical disabilities and/or developmental delay.
- Obliteration of perimesencephalic cistern on initial head CT/MRI suggesting prolonged hypoxic ischemic insult/herniation syndrome.
- Initial hospital ICP \> 40 mm Hg.
- Hemodynamic instability at the time of screening defined as SBP \<90 mmHg, ongoing fluid resuscitation and/or requirement for inotropic support to maintain MAP at or above normal for age - does not include CPP based inotropic support. IVF alone does not exclude from enrollment.
- Uncorrected coagulopathy at the time of bone marrow harvest defined as INR \> 1.6, PTT \> 38 sec; PLT\< 100,000; Fibrinogen \< 100 g/dL.
- Unstable pelvic fractures defined as requiring early operative fixation.
- Pulmonary contusions defined as a chest x-ray with non-anatomic opacification and/or PaO2:FiO2 ratio \< 250 associated with the mechanism of injury.
- Greater than AAST Grade 3 solid or hollow visceral injury of the abdomen and/or pelvis as diagnosed by CT or other imaging.
- Spinal cord injury diagnosed by CT/MR imaging or clinical findings.
- Persistent hypoxia defined as SaO2 \< 94% for \> 30 minutes occurring at any time from hospital admission to time of consent.
- Positive pregnancy test, if applicable.
- Concurrent participation in an interventional drug/device research study.
- Unwillingness to return for follow-up visits.
- Contraindications to MRI.
- Penetrating brain injury.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2020
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01851083
Start Date
August 1 2013
End Date
October 12 2020
Last Update
November 20 2020
Active Locations (2)
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1
Phoenix Children's Hospital I University of Arizona
Phoenix, Arizona, United States, 85006
2
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030